Cell & Gene Therapy
Regulatory Science

Creative Medical claims 93% response rate in Ultrasome knee OA pilot

CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.
CELZ reported its cell-free Ultrasome therapy met its primary endpoint in a knee osteoarthritis pilot, with no serious adverse events observed.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Crescent Biopharma posts Q1 2026 results with $189m cash runway

The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Cristcot to present CESSA corticosteroid data at DDW 2026

Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Greenwich LifeSciences delays 10-K amid FLAMINGO-01 data update

Greenwich LifeSciences has pushed its 2025 annual filing to May while reporting a 70–80% recurrence reduction in preliminary Phase III open-label data.
Greenwich LifeSciences has pushed its 2025 annual filing to May while reporting a 70–80% recurrence reduction in preliminary Phase III open-label data.
The Biotech Times Editorial Team  · 
Pharmaceuticals

InnoCare doses first patient in Phase III orelabrutinib SLE trial

InnoCare has initiated a registrational Phase III study of its BTK inhibitor orelabrutinib in SLE, backed by promising Phase IIb data showing a 57% SRI

The Phase III study is a randomised, double-blind, placebo-controlled, multicentre design. The primary endpoint is the SLE Response Index-4 (SRI-4) response rate at Week 52 — the same validated composite measure used in the preceding Phase IIb programme.

InnoCare's confidence in advancing to Phase III rests on a Phase IIb readout in which orelabrutinib 75 mg once daily produced a statistically significant improvement in SRI-4 response versus placebo at Week 48, recording rates of 57.1% against 34.4% (p < 0.05). The results were achieved under stringent steroid-tapering requirements, which the company argues makes the signal more clinically meaningful than comparisons in which corticosteroid use was unrestricted.

The Biotech Times Editorial Team  · 
Pharmaceuticals

Kestrel Therapeutics doses first patient in FALCON pan-KRAS trial

Watertown biotech Kestrel has entered a warrant deal with AbbVie worth up to $1.45bn alongside dosing the first patient in its KST-6051 Phase
Watertown biotech Kestrel has entered a warrant deal with AbbVie worth up to $1.45bn alongside dosing the first patient in its KST-6051 Phase
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Mesoblast completes enrolment in Phase 3 chronic back pain trial

Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.
Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Nicox cuts net loss to €2.4m as NCX 470 NDA filing nears

The French ophthalmology biotech doubled revenue to €16.8m in 2025 and expects to file its glaucoma candidate NCX 470 with the FDA by summer
The French ophthalmology biotech doubled revenue to €16.8m in 2025 and expects to file its glaucoma candidate NCX 470 with the FDA by summer
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Ocular Therapeutix enrols first patient in SOL-X wet AMD extension trial

The Bedford-based biotech has opened a three-year extension study for AXPAXLI, its long-acting intravitreal hydrogel, aiming to demonstrate disease-modifying benefit in
The Bedford-based biotech has opened a three-year extension study for AXPAXLI, its long-acting intravitreal hydrogel, aiming to demonstrate disease-modifying benefit in
The Biotech Times Editorial Team  · 
Pharmaceuticals

Telix OPTIMAL-PSMA dosimetry data back TLX597-Tx dose push

Phase 2 data presented at IPCS 2026 show low off-target radiation, supporting dose intensification and a new mHSPC trial for Telix's next-generation
Phase 2 data presented at IPCS 2026 show low off-target radiation, supporting dose intensification and a new mHSPC trial for Telix's next-generation
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Orchard Therapeutics wins Innovation Passport for OTL-201 in MPS-IIIA

OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
The Biotech Times Editorial Team  · 
Pharmaceuticals

Oruka Therapeutics launches $500m public offering on Nasdaq

The Menlo Park psoriasis biotech is seeking up to $575m including an overallotment option, with Leerink Partners and Goldman Sachs among the bookrunners.
The Menlo Park psoriasis biotech is seeking up to $575m including an overallotment option, with Leerink Partners and Goldman Sachs among the bookrunners.
The Biotech Times Editorial Team  · 
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